ISO 13485 – Implementation, Registration and Beyond · ISO 13485 – Implementation, Registration...

ISO 13485 – Implementation, Registration and Beyond Nancy Ruth, Director, Medical Devices

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Agenda

1. Medical Device Quality Systems and ISO 13485 2. Quality System Planning 3. Documentation Requirements 4. Implementation 5. Certification/Registration 6. Beyond Registration 7. ISO 13485 Future 8. Medical Device Single Audit Program


Company Background

• OptumInsight Canada, Inc – formerly CanReg Inc. – regulatory consulting drugs, medical devices, natural health products; medical information, pharmacovigilance etc

• Medical device consulting – product and establishment registration, quality systems; strategy, assessments, regulatory inspection preparation – Canadian, US, EU – ISO 13485:2003 CMDCAS (Canadian Medical Device Conformity

Assessment System); FDA QS Regulation; EN ISO 13485:2003 CE mark – Regulatory strength, quality system experience


1. Medical Device Quality Systems and ISO 13485 • Quality System: The organizational structure, processes, responsibilities,

procedures, and resources for implementing quality management.

US: • Quality System Regulation – 21 CFR 820 • ISO 13485:1996 elements • FDA inspected • Third Party accredited auditors Canada: • ISO 13485:2003 CMDCAS certification – Class II, III IV devices • Third party audit program with registrars EU: • CE marking • Conformity assessment to Medical Devices Directive • Routes to conformity – quality system assessment

– EN ISO 13485:2003 – Audit by Notified Body – third party


1. Medical Device Quality Systems and ISO 13485 • ISO 13485:2003 and QS Reg • Very similar • Complementary

– Control of documents, facility, personnel, management, design, manufacturing, storage, delivery, improvement - Regulatory requirements


1. Medical Device Quality Systems and ISO 13485 • Other jurisdictions also require medical device QS

– China, Japan, Australia – Emerging markets


1. Medical Device Quality Systems and ISO 13485

Overview of main sections that detail requirements: • Section 4 – Quality Management System - basic structure

and key elements • Documented policy and measurable objectives

– Relevant at all levels - challenge • Top Management support and commitment. • Documentation, documentation and more documentation.


1. Medical Device Quality Systems and ISO 13485 • Section 5 – Management Responsibility • Outlines Management roles in quality system – ensure effectiveness. • Management Commitment.

– Management leads the way


1. Medical Device Quality Systems and ISO 13485 • Section 6 – Resource Management • Identifies resources necessary to maintain an effective quality system • Staff training, competence evaluation • Work area resources


1. Medical Device Quality Systems and ISO 13485

• Section 7 – Product Realization • Risk Management • Customer and Regulatory Requirements • Design and Development • Purchasing • Production and Service Provisions • Process Validation • Product Identification • Conformity, Control, Measuring Devices


1. Medical Device Quality Systems and ISO 13485 • Section 8 – Measurement, Analysis and Improvement • Monitoring information to meet the customer’s requirements –complaints, feedback, post market • Auditing • CAPA (Corrective Action/Preventive Action)

• Root Cause Analysis • Analyzing Data to prevent occurrences

• Process Measurements – product tests • Control of Non-conforming Product • Improvement – effectiveness of the QS


2. Quality System Planning • When to start planning

– New company – Expanding market to additional jurisdictions – New product(s) – new medical device, or adding medical device lines – Risk management, design controls, supplier controls

• Never too soon


2. Quality System Planning • Scope of quality system

• Regulations for target market(s) – Device classification, regulatory pathway – Requirements, exclusions eg design

• Where company lines include other product types (drugs, supplements, natural health products, cosmetics) – May have existing quality documents – Integrate into one system – Include other requirements for specific product types – Avoid duplication, gaps


2. Quality System Planning

• Team – Critical – In house – ownership, action – Quality Representative, operations, management – Training, experience – Outside expertise – Not a last-man-in-the-door job!


2. Quality System Planning • Quality plan

– Document it – flow chart, table, list, spreadsheet, project management tool – Define responsibilities, timelines, progress review


2. Quality System Planning • Timeline to audit

– Target for product launch or new market introduction? – Time to develop, implement, gather evidence of compliance

• Product/certificate/licence

– Registrar/auditor booking


3. Documentation Requirements

• Quality policy, quality objectives – Company thinking – Goals/targets –measureable, monitor – Must be relevant at all levels

• Quality manual – high level • Standard operating procedures

– process maps, forms – work instructions

• Records – evidence that the system complies with the plans



• Include references to regulatory requirements, standards, guidance – Canadian Medical Devices Regulations, guidance documents/policies for

recall, mandatory problem reports, complaint handling, labelling – FDA QS Regulation 21CFR820, guidance documents – EU Medical Devices Directive 93/42/EEC, MEDDEV guidances – ISO 14971 (Risk Management), other ISO standards as applicable to the

product(s) • Recognized standards – vary per jurisdiction


3. Documentation Requirements • Ensure the documents meet requirements of the standard, regulations • Reflect actual practice • Paper or electronic system • List of controlled external documents

– copies of standards, regulations, manuals etc • Paper or electronic format

– Have a documented process to keep current • Specify interval to verify the latest versions are on hand, who is responsible



• Strategy without existing QS documents: – Number them to follow the

standard or the QS Reg sections

– Logical, easy to find where requirements are addressed

List of Controlled Documents

Number Title Effective Date

QMM rev 2

Quality Management Manual

Sept 1/13

401.01 Document Control Aug 9/12

402.01 Records Jul 31/12

501.03 Management Review

Sep1/13

601.01 Training Jan 4/12

701.02 Purchasing May15/ 13

702.01 Risk Management June 9/12

801.01 Internal audit May16/12



• Strategy with existing QS documents – adding medical devices for

Canada - cross reference, add additional procedures – customize approach –”knit” the system together

• Drug Establishment Licence – GMP • ISO 9001 • US FDA OTC • CE marked for EU • Corporate policies/procedures



• Commercially available QS system templates – Caveats – Generic may address standard requirements: – May not capture:

• company specific practices, responsibilities • regulatory requirements

– Initial registration ? – maybe ok – Evidence of implementation, effectiveness –

downstream audits? – maybe not – Custom system – in house expertise or outside help


4. Implementation • Documents reviewed, approved, ready for use!

– Training first • all involved staff, all levels, relevant, tailored • Matrix – correlates responsibilities to documents • Training records – evidence • Effectiveness • Use examples that relate to your business

– Comparisons with life scenarios helpful

– One complete internal audit, one full management review before registration audit required


5. Certification/Registration

• “Registration” • Required for Canada, EU • Not required if marketing only in US

– May desire if supplying products/mfg service to customers • Registrar

– recognized by Health Canada and SCC – Notified Body for EU if CE marking – FDA Third Party

• Partner – registration, on-going commitment

• Provide a service – business – caveat emptor – value for investment – “good fit” – registrar, auditor



• Standardized program, registrar training – Difference in contracts, service delivery, interpretation, audit

scheduling, costs • Quotations

– recommend obtain several – compare • Deposit, annual fee, charge for certificate and changes, per diem rate, number

of audit days/auditors, surveillance audit charges etc

• Auditors – request CV – appropriate experience for company operation, product type(s)



• Documentation study (Stage 1) – review QS documents in advance - on site preferred by the registrars –

exceptions possible (off site review – where experience with implementation – some conditions) • compliance with standard– quality manual, procedures • Auditor preference – e-copy, paper

– As complete as possible • make auditor’s job easy • good foundation for relationship

– Report – time to address deficiencies


5. Certification/Registration • On site audit (Stage 2)

– Company practice vs written policies procedures? – Review documented evidence

• records – Impressions important – Organized, clean, tidy, efficient – Management presence, key personnel briefed, available – Documents available



• Audit findings – Non-conformances/non-conformities/non-compliances – communicated as

audit progresses • Major • Minor

– Observations • Positive comments • Opportunities for improvement, recommendations • May evolve to nonconformances downstream

– Corrections during audit – possible • Caution – hasty vs well planned


5. Certification/Registration • Audit Report

– Closing meeting – summarize findings – Report- draft at closing meeting or may follow

• Internal process at registrar for review/approval

– Non-conformances, conditions for responses/actions/timelines


5. Certification/Registration • Audit follow up

– Respond to non-conformances – propose actions, timelines – Auditor

• approves plan, follow up determined – off site, next visit

• Registrar – review/approval of corrective actions - certificate issued



• Certificate – Content important – Health Canada guidance, scope templates, “effective” date

• Difference from EU certificates – Auditor should discuss details during audit (scope, activities, products, company name and address etc) - May provide draft – Cost to change certificate – varies – Unacceptable certificate

• rejected by Health Canada • Delay in licensing • Effect on product launch


6. Beyond Registration • Registration – big achievement • End of beginning • Ongoing commitment – management, quality personnel • 3 yr cycle – minimum annual surveillance audit

– Shorter than full registration – follow up non-conformances, regulatory compliance, half of quality

system elements • FDA inspections

– QSIT (Quality System Inspection Technique) method – PMA (preapproval inspection), 510(k) manufacturers – cyclic; directed


6. Beyond Registration

• Challenges – Staff with multiple responsibilities- conflicting priorities – Inexperience – Resources, training – Problem areas:

• CAPA, complaint follow up, root cause, investigations, verify effectiveness of action

• internal audit and follow up, management review • documentation/records


6. Beyond registration

• Notifications to registrar of changes – Changes to quality system eg manufacturing site, critical

supplier of product, scope – products, activities • may need audit before implementation • auditor preparation for next scheduled audit

– Change of address, contact – Advice from registrar – partner – valuable to keep in

touch • Notifications/submissions to regulator


7. ISO 13485 - Future • Expected changes to ISO 13485:2003 – next iteration of

the standard drafted, finalization 2014, 2015? • If already certified, prepare for changes • If planning certification before the new version, plan for the

changes


7. ISO 13485 - Future Proposed Changes to ISO 13485: • More specific requirements included throughout the device life-cycle:

– Design and development – Production – Storage and distribution – Installation – Servicing

• Clearly identify organization’s role under applicable regulatory requirements.

• New definitions: – Medical device software – Post market surveillance – Performance evaluation – Risk management


7. ISO 13485 - Future Proposed Changes (cont’d) • New detailed requirements identified in subsections:

– Design and development planning – Design and development verification – Design and development validation – Review of changes affecting the design of the device – Supplier selection, evaluation and approval – Verification of purchased product – Complaint handling – Response to nonconforming product


7. ISO 13485 - Future Proposed Changes - Timeline • Plan to revise/publish before the next version of ISO 9001 (suggested

ISO 9001:2015) • Comments to the “Committee Draft” by August 10, 2013 • Comments discussed by International Committee by October, 2013 • Prepare “Draft International Standard” for circulation and wider

international public comment by October, 2013 • Target date for publishing late 2014 or early 2015


8. Medical Device Single Audit Program (MDSAP)

• Under development by a Work Group of IMDRF (International Medical Device Regulators Forum -formerly GHTF – Global Harmonization Task Force)

• IMDRF Mission:

– accelerate international medical device regulatory convergence – promote efficient and effective regulatory model for medical devices that is responsive

to emerging challenges in the sector while protective/maximizing public health/safety

• Work Group (WG(PD1)/N3R3 developing standard set of requirements for

auditing organizations doing quality system regulatory audits of medical device manufacturers

• Will apply to competent authority auditing groups and inspectorates + third party auditing organizations

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Objectives: • Single audit program with confidence in outcomes;

• Appropriate regulatory oversight of manufacturers’ quality systems, minimize

regulatory burden on industry;

• Promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among Participants, while respecting the sovereignty of each country;

• Promote greater global alignment of regulatory approaches, technical requirements based on international standards and best practices;

• Promote consistency, predictability, transparency of regulatory programs by standardizing oversight over third party auditing organizations

• Leverage, where appropriate, existing conformity assessment structures.

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• Expected program outputs/benefits: develop, manage and oversee a single audit program that will allow a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions. • Less burdensome for Medical Device Manufacturers • Based on a three year cycle • International Coalition of Countries

• Currently US, Canada, Brazil, Australia • Working group includes EU, Asia, Japan

• More efficient • Pooled technology expertise, resources • Improved safety • Modelled after Health Canada’s CMDCAS third party programs • Best Practices of Canadian and American systems • Unannounced Audits • 4 documents target end of 2013 • Comment period • Pilot program will follow



Audit Facilitators • Code of Conduct • Initial, Surveillance and Re-recognition Criteria • Standard Requirements for Auditing Organizations • Auditor Competency Assessments • Regulatory Authority Assessed • Standardized Rating System for audit findings • Source Documents

– WG(PD2)/N3R5 – Recognition and Monitoring of Organizations undertaking Audits of Medical Device Manufactures

– ISO/IEC 17021:2011 – EU Draft Legislation of Requirements for Notified Bodies – EU MEDEV 2.10-2 Rev 1:2001 – Designation and Monitoring of Notified

Bodies within the Framework of EC Directives on Medical Devices



Summary

• Planning – Training, experience, help within/outside

• Good quality documents – Cover requirements, current practice

• Preparation for audit – Organized, impressions – Post certification - keep momentum – Don’t get behind – Document, document, document

• Future changes - Awareness, impact, planning

• Teamwork – Shared responsibility

Thank you!

Contact information Nancy Ruth Director Medical Devices 905 690 5790 [email protected]

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